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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 121 12 15 000
Date submitted: 12/29/2015
Manufacturer:GE Healthcare
Device Type:Drive Gas Check Valve of certain Anesthesia products.
Description:Anesthesia products
Medical Device Identifier:Specific Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices shipped from the GE Healthcare manufacturing center and installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).
Reason of Field Safety Corrective Action:The Drive Gas Check Valve could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle.
Remedy Action:GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:AD60DFCA51307
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf